IRBESARTAN 75 mg Tablet, 1,000-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Angiotensin 2 Receptor Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Irbesartan is used for two main things. First, it lowers high blood pressure, which helps protect you from serious events like stroke and heart attack. Second, if you have type 2 d...
- Food doesn't affect how well irbesartan works, so you can take it with or without a meal — whatever fits your routine best. The most important thing is to take it around the same t...
- Does it matter if I take it with food or at a certain time of day?
- Most people do fine on irbesartan. The most common things you might notice are mild diarrhea, heartburn, fatigue, or occasional dizziness — especially when you stand up quickly. Th...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Irbesartan — tap one for details:
Irbesartan may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2325 | $232.50 / 1000 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Irbesartan 75 mg 33342-0047-07 | Macleods | 30 tablets | $0.083 | AB | Availability likely | — |
| Irbesartan 75 mg 43547-0374-03 | Solco | 30 tablets | $0.083 | AB | Availability likely | — |
| Irbesartan 75 mg 62135-0976-30 | Chartwell | 30 tablets | $0.083 | AB | Availability likely | — |
| Irbesartan 75 mg 62332-0041-30 | Alembic | 30 tablets | $0.083 | AB | Availability likely | — |
| Irbesartan 75 mg 72603-0670-01 | NorthStar | 90 tablets | $0.083 | AB | Availability likely | — |
| Irbesartan 75 mg 29300-0212-05 | Unichem | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 31722-0160-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 31722-0729-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 42291-0940-90 | AvKARE | 90 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 42658-0121-01 | Hisun | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mgthis 46708-0439-91 | Alembic | 1000 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 50228-0160-05 | ScieGen | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 59746-0447-05 | Jubilant | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 63629-8259-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Irbesartan 75 mg 65162-0284-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 65862-0637-05 | Aurobindo | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 70518-2685-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 71205-0379-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 71335-1547-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 71335-2745-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 72189-0201-90 | direct | 90 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 72205-0327-05 | Novadoz | 500 tablets | — | AB | FDA listed | — |
| Irbesartan 75 mg 83008-0085-30 | Quality | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0439-30 | 30 TABLET in 1 BOTTLE (46708-439-30) | 2016-07-01 | Active |
| 46708-0439-31 | 100 TABLET in 1 BOTTLE (46708-439-31) | 2016-07-01 | Active |
| 46708-0439-71 | 500 TABLET in 1 BOTTLE (46708-439-71) | 2016-07-01 | Active |
| 46708-0439-90 | 90 TABLET in 1 BOTTLE (46708-439-90) | 2016-07-01 | Active |
| 46708-0439-91 You're viewing this | 1000 TABLET in 1 BOTTLE (46708-439-91) | 2016-07-01 | Active |
You're viewing the largest of 5 pack sizes for this product.
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue Irbesartan Tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue Irbesartan Tablets as soon as possible. (5.1) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
(5.1)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Irbesartan Tablets USP is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) • Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2).
1.1Hypertension Irbesartan Tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Irbesartan Tablets USP may be used alone or in combination with other antihypertensive agents.
1.2Nephropathy in Type 2 Diabetic Patients Irbesartan Tablets USP are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, Irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.2)].
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Ind ication D o s e Hypertension (2.2) 150 to 300 mg once daily Diabetic Nephropathy (2.3) 300 mg once daily
2.1General Considerations Irbesartan Tablets may be administered with other antihypertensive agents and with or without food.
2.2Hypertension The recommended initial dose of Irbesartan Tablet is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure [see Clinical Studies (14.1)].
2.3Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies (14.2)].
2.4Dose Adjustment in Volume- and Salt-Depleted Patients The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) [see Warnings and Precautions (5.2)].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Irbesartan Tablets 75 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L131” on one side and “75” on other side. Irbesartan Tablets 150 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L132” on one side and “150” on other side. Irbesartan Tablets 300 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L133” on one side and “300” on other side. • Tablets: 75 mg, 150 mg, 300 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Irbesartan Tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not co-administrate aliskiren with Irbesartan Tablets in patients with diabetes. • Hypersensitivity to any component of this product. (4) • Co-administration with aliskiren in patients with diabetes. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration. (5.2) • Monitor renal function and serum potassium. (5.3)
5.1Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
When pregnancy is detected, discontinue Irbesartan Tablets as soon as possible [see Use in Specific Populations (8.1)] .
5.2Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g. those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with Irbesartan Tablets. Correct volume or salt depletion prior to administration of Irbesartan Tablets or use a lower starting dose [see Dosage and Administration (2.4)].
5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing acute renal failure or death on Irbesartan Tablets. Monitor renal function periodically in these patients.
Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Irbesartan Tablets [see Drug Interactions (7.3)].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: • Hypotension in Volume- or Salt-depleted Patients [see Warnings and Precautions (5.2)] • Impaired Renal Function [see Warnings and Precautions (5.3)] • Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension Irbesartan Tablets have been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall.
This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more. In placebo-controlled clinical trials, the following adverse reactions were reported in at least 1% of patients treated with Irbesartan Tablets (n=1965) and at a higher incidence versus placebo (n=641), excluding those too general to be informative and those not reasonably associated with the use of drug because they were associated with the condition being treated or are very common in the treated population, include: diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%), and fatigue (4% vs 3%).
Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. In placebo-controlled studies, the incidence of cough in irbesartan-treated patients was 2.8% versus 2.7% in patients receiving placebo. Nephropathy in Type 2 Diabetic Patients Hyperkalemia: In the Irbesartan Diabetic Nephropathy Trial (IDNT) (proteinuria ≥900 mg/day, and serum creatinine ranging from 1 to 3 mg/dL), the percent of patients with potassium >6 mEq/L was 18.6% in the Irbesartan Tablets group versus 6% in the placebo group.
Discontinuations due to hyperkalemia in the Irbesartan Tablets group were 2.1% versus 0.4% in the placebo group. In IDNT, the adverse reactions were similar to those seen in patients with hypertension with the exception of an increased incidence of orthostatic symptoms which occurred more frequently in the Irbesartan Tablets versus placebo group: dizziness (10.2% vs 6%), orthostatic dizziness (5.4% vs 2.7%) and orthostatic hypotension (5.4% vs 3.2%).
6.2Post-Marketing Experience The following adverse reactions have been identified during post-approval use of Irbesartan Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. Urticaria; angioedema (involving swelling of the face, lips, pharynx, and/or tongue); increased liver function tests; jaundice; hepatitis; hyperkalemia; thrombocytopenia; increased CPK; tinitus.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Lithium: Risk of lithium toxicity (7) • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. (7) • Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. (7)
7.1Agents Increasing Serum Potassium Coadministration of Irbesartan Tablets with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients.
7.2Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. Monitor lithium levels in patients receiving irbesartan and lithium.
7.3Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including irbesartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving irbesartan and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including irbesartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.
7.4Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.
Closely monitor blood pressure, renal function and electrolytes in patients on Irbesartan Tablets and other agents that affect the RAS. Do not co-administer aliskiren with Irbesartan Tablets in patients with diabetes. Avoid use of aliskiren with Irbesartan Tablets in patients with renal impairment (GFR <60 mL/min).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Nursing Mothers: Potential for adverse effects in infant. (8.3)
8.1Pregnancy Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
When pregnancy is detected, discontinue Irbesartan Tablets as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.
Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment.
If oligohydramnios is observed, discontinue Irbesartan Tablets, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Closely observe infants with histories of in utero exposure to Irbesartan Tablets for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)] . Irbesartan crosses the placenta in rats and rabbits. In pregnant rats given irbesartan at doses greater than the maximum recommended human dose (MRHD), fetuses showed increased incidences of renal pelvic cavitation, hydroureter and/or absence of renal papilla.
Subcutaneous edema also occurred in fetuses at doses about 4 times the MRHD (based on body surface area). These anomalies occurred when pregnant rats received irbesartan through Day 20 of gestation but not when drug was stopped on gestation Day 15. The observed effects are believed to be late gestational effects of the drug.
Pregnant rabbits given oral doses of irbesartan equivalent to 1.5 times the MRHD experienced a high rate of maternal mortality and abortion. Surviving females had a slight increase in early resorptions and a corresponding decrease in live fetuses [see Nonclinical Toxicology (13.2)] . Radioactivity was present in the rat and rabbit fetus during late gestation and in rat milk following oral doses of radiolabeled irbesartan.
8.3Nursing Mothers It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue Irbesartan Tablets.
8.4Pediatric Use In infants with histories of in utero exposure to an angiotensin II receptor antagonist observe for hypotension, oliguria, and hyperkalemia. If oliguria occurs, support blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.
Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years. Irbesartan Tablets has not been studied in pediatric patients less than 6 years old.
8.5Geriatric Use Of 4925 subjects receiving Irbesartan Tablets in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3%) were 75 years and over. No overalldifferences in eff…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
When pregnancy is detected, discontinue Irbesartan Tablets as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.
Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment.
If oligohydramnios is observed, discontinue Irbesartan Tablets, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Closely observe infants with histories of in utero exposure to Irbesartan Tablets for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)] . Irbesartan crosses the placenta in rats and rabbits. In pregnant rats given irbesartan at doses greater than the maximum recommended human dose (MRHD), fetuses showed increased incidences of renal pelvic cavitation, hydroureter and/or absence of renal papilla.
Subcutaneous edema also occurred in fetuses at doses about 4 times the MRHD (based on body surface area). These anomalies occurred when pregnant rats received irbesartan through Day 20 of gestation but not when drug was stopped on gestation Day 15. The observed effects are believed to be late gestational effects of the drug.
Pregnant rabbits given oral doses of irbesartan equivalent to 1.5 times the MRHD experienced a high rate of maternal mortality and abortion. Surviving females had a slight increase in early resorptions and a corresponding decrease in live fetuses [see Nonclinical Toxicology (13.2)] . Radioactivity was present in the rat and rabbit fetus during late gestation and in rat milk following oral doses of radiolabeled irbesartan.
🧒 Pediatric Use ▾
8.4Pediatric Use In infants with histories of in utero exposure to an angiotensin II receptor antagonist observe for hypotension, oliguria, and hyperkalemia. If oliguria occurs, support blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.
Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years. Irbesartan Tablets has not been studied in pediatric patients less than 6 years old.
🧓 Geriatric Use ▾
8.5Geriatric Use Of 4925 subjects receiving Irbesartan Tablets in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3%) were 75 years and over. No overalldifferences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. [See Clinical Pharmacology (12.3) and Clinical Studies (14.1) . ]
🆘 Overdosage ▾
10 OVERDOSAGE No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Irbesartan is not removed by hemodialysis. Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m 2 basis, respectively.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT 1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeostasis. Irbesartan is a specific competitive antagonist of AT 1 receptors with a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor and no agonist activity.
Blockade of the AT 1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure. Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis.
12.2Pharmacodynamics In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose-dependent inhibition of the pressor effect of angiotensin II infusions. Inhibition was complete (100%) 4 hours following oral doses of 150 mg or 300 mg and partial inhibition was sustained for 24 hours (60% and 40% at 300 mg and 150 mg, respectively). In hypertensive patients, angiotensin II receptor inhibition following chronic administration of irbesartan causes a 1.5- to 2-fold rise in angiotensin II plasma concentration and a 2- to 3-fold increase in plasma renin levels.
Aldosterone plasma concentrations generally decline following irbesartan administration, but serum potassium levels are not significantly affected at recommended doses. In hypertensive patients, chronic oral doses of irbesartan (up to 300 mg) had no effect on glomerular filtration rate, renal plasma flow, or filtration fraction. In multiple dose studies in hypertensive patients, there were no clinically important effects on fasting triglycerides, total cholesterol, HDL-cholesterol, or fasting glucose concentrations.
There was no effect on serum uric acid during chronic oral administration, and no uricosuric effect.
12.3Pharmacokinetics Absorption The oral absorption of irbesartan is rapid and complete with an average absolute bioavailability of 60% to 80%. Following oral administration of Irbesartan Tablets, peak plasma concentrations of irbesartan are attained at 1.5 to 2 hours after dosing. Food does not affect the bioavailability of irbesartan.
Irbesartan exhibits linear pharmacokinetics over the therapeutic dose range. Distribution Irbesartan is 90% bound to serum proteins (primarily albumin and α 1 -acid glycoprotein) with negligible binding to cellular components of blood. The average volume of distribution is 53 to 93 liters.
Studies in animals indicate that radiolabeled irbesartan weakly crosses the blood-brain barrier and placenta. Irbesartan is excreted in the milk of lactating rats. Elimination Total plasma and renal clearances are in the range of 157 to 176 mL/min and 3 to 3.5 mL/min, respectively.
The terminal elimination half-life of irbesartan averages 11 to 15 hours. Steady- state concentrations are achieved within 3 days. Limited accumulation of irbesartan (<20%) is observed in plasma upon repeated once-daily dosing and is not clinically relevant.
Metabolism Irbesartan is an orally active agent that does not require biotransformation into an active form. Irbesartan is metabolized via glucuronide conjugation and oxidation. Following oral or intravenous administration of 14 C-labeled irbesartan, more than 80% of the cir…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT 1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeostasis. Irbesartan is a specific competitive antagonist of AT 1 receptors with a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor and no agonist activity.
Blockade of the AT 1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure. Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Irbesartan Tablets USP 75 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L131” on one side and “75” on other side. They are supplied as follows: NDC 46708-439-30 Bottles of 30 NDC 46708-439-90 Bottles of 90 NDC 46708-439-31 Bottles of 100 NDC 46708-439-71 Bottles of 500 NDC 46708-439-91 Bottles of 1000 Irbesartan Tablets USP 150 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L132” on one side and “150” on other side.
They are supplied as follows: NDC 46708-440-30 Bottles of 30 NDC 46708-440-90 Bottles of 90 NDC 46708-440-31 Bottles of 100 NDC 46708-440-71 Bottles of 500 NDC 46708-440-91 Bottles of 1000 Irbesartan Tablets USP 300 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L133” on one side and “300” on other side. They are supplied as follows: NDC 46708-441-30 Bottles of 30 NDC 46708-441-90 Bottles of 90 NDC 46708-441-31 Bottles of 100 NDC 46708-441-71 Bottles of 500 NDC 46708-441-91 Bottles of 1000 Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Irbesartan Tablet is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[ p -( o -1 H -tetrazol-5 ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C 25 H 28 N 6 O, and the structural formula: Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5.
It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan Tablets USP is available for oral administration in unscored tablets containing 75 mg, 150 mg and 300 mg of Irbesartan.
Inactive ingredients include: lactose, povidone k-30, croscarmellose sodium and magnesium stearate. Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Pregnancy Advise female patients of childbearing age about the consequences of exposure to Irbesartan Tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Potassium Supplements Advise patients receiving Irbesartan Tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1)]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India.
Revised: 06/2016